Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor
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|ClinicalTrials.gov Identifier: NCT00103168|
Recruitment Status : Completed
First Posted : February 8, 2005
Last Update Posted : July 9, 2018
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after surgery may kill any remaining tumor cells. It is not yet known whether imatinib mesylate is more effective than observation only in treating gastrointestinal stromal tumor.
PURPOSE: This randomized phase III trial is studying imatinib mesylate to see how well it works compared to observation only in treating patients who have undergone surgery for localized gastrointestinal stromal tumor.
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumor||Drug: imatinib mesylate||Phase 3|
- Assess whether there is a difference in overall survival between intermediate and high-risk localized GIST patients undergoing complete surgery alone and those undergoing complete surgery plus adjuvant imatinib mesylate 400 mg daily for two years Secondary
- Assess whether there is a difference in relapse-free survival and relapse-free interval between GIST undergoing complete surgery alone and those undergoing surgery + adjuvant Imatinib mesylate 400 mg daily for two years.
- Determine the safety of this drug in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, risk category (high vs intermediate), tumor site (gastric vs other), and resection level (R0 vs R1).
- Arm I: Patients receive adjuvant oral imatinib mesylate once daily for 2 years in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients are observed (without receiving further antitumoral therapy) every 3 months for 2 years.
After completion of study treatment, patients in arm I are followed every 3 months for 2 years. All patients are then followed every 4 months for 3 years and at least annually thereafter.
PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study within 3.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||908 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intermediate and High Risk Localized, Completely Resected, Gastrointestinal Stromal Tumors (GIST) Expressing KIT Receptor: A Controlled Randomized Trial on Adjuvant Imatinib Mesylate (Glivec) Versus No Further Therapy After Complete Surgery|
|Actual Study Start Date :||December 2004|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||September 2017|
Experimental: Imatinib mesylate
400 mg/day for 2 years
Drug: imatinib mesylate
400 mg/day for 2 years
|No Intervention: Control|
- Overall survival
- Relapse-free survival
- Relapse-free interval
- Adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103168
|Study Chair:||Paolo G. Casali, MD||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|
|Study Chair:||Axel Le Cesne, MD||Gustave Roussy, Cancer Campus, Grand Paris|
|Study Chair:||Andres Poveda, MD||Instituto Valenciano De Oncologia|